MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER; SIMILAR DEVICE D133601, PMA # P030031/S053

Catalog Number D133604IL

Device Problems Loss of or Failure to Bond (1068); Temperature Problem (3022); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2017

Event Type  malfunction  

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.(b)(4).

Event Description

It was reported that a patient underwent a procedure with a thermocool® smart touch¿ electrophysiology catheter and no temperature was displayed.The catheter was changed to another and the issue resolved.The procedure was completed with no patient consequence.This event was originally assessed as not mdr reportable because the potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.The device was returned to the biosense webster failure analysis lab and on (b)(6) 2018, it was discovered that the catheter tip section is bent approximately 2 cm from the tip of the catheter.Sharp edge was also found on electrode #4.In addition, on (b)(6) 2018, it was discovered that the polyurethane was not attached to the distal end of the electrode #4.This finding has been reassessed as mdr reportable because electrode ring edges that appear to be sharp or rough may cause a potential risk to the patient.The awareness date has been reset to (b)(6) 2018, the date the reportable finding was discovered.

Manufacturer Narrative

It was reported that a patient underwent a procedure with a thermocool® smart touch¿ electrophysiology catheter and no temperature was displayed.The returned device was visually inspected and the tip was found bent with sharp edges on electrode # 4 (which made this complaint mdr reportable) and the polyurethane is not attached to the electrode.Per the event, the catheter was tested for electrical performance and stockert compatibility and it was found within specifications.Then, a coolflow pump test and a deflection test were performed and the catheter passed specifications.The catheter was evaluated for eeprom, and the functionality of the sensor catheter was tested on the carto system.Eeprom data demonstrates the catheter was properly calibrated during manufacturing.The catheter was recognized by carto 3 system; however, error 106 was displayed.The catheter was then dissected and it was determined that the root cause was an internal failure of the sensor.Then, per the damage observed, a scanning electron microscope (sem) testing was performed and the results showed evidence of scratches, mechanical damage and a hole on the surface of the peek housing.No sharp edges were observed on the surface of the ring, edges were found rounded.It is possible that the damage was generated with an unknown object.No other anomalies were observed.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.During manufacturing process, all the catheters are inspected for visual damages before packaging.On line inspections and functional tests are in place to prevent this type of damage from leaving the facility.The customer complaint cannot be confirmed.The root cause of the loss of electrical continuity at the sensor could not be determined.The root cause of the damage observed does not appear to be caused by any internal bwi processes since there is evidence that the device was manufactured in accordance with documented specification and procedures, it could be related to excessive force during the manipulation of the catheter.Manufacturer's ref.No: (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER
• Type of Device: SIMILAR DEVICE D133601, PMA # P030031/S053
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 7244150
• MDR Text Key: 99327241
• Report Number: 2029046-2018-01150
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: D133604IL
• Device Lot Number: 17711605M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2018
• Date Manufacturer Received: 01/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1